Overall survival (OS) [ Time Frame: from randomization until death or end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ] [ Designated as safety issue: Yes ]

Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from study day 1 to end of efficacy treatment period [ Time Frame: study day 1 until end of efficacy treatment period ] [ Designated as safety issue: No ]

Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from week 5 (day 29) to end of efficacy treatment period [ Time Frame: Study day 29 to end of efficacy treatment period ] [ Designated as safety issue: No ]

Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.

Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.

18 years of age or older at screening.

Life expectancy greater than 6 months based on the judgment of the investigator and documented during screening.

Hemoglobin level less than or equal to 11.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomization (retest in screening is acceptable).

Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.

Subjects must have had a baseline scan (CT, MRI, or PET/CT) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.

Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative.

Exclusion Criteria:

Known primary benign or malignant hematologic disorder which can cause anemia.

History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.

History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.

Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.

Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.

Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.

Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.

Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).

Previously randomized to this study.

Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858364